FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Surgical Scissors FS-200
DI: 04953170401077
·
Model: FS-200L
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Single Use Surgical Scissors FS-200
- Primary DI
- 04953170401077
- Version / Model
- FS-200L
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-17
- Public Version
- 2
- Public Version Date
- 2021-12-17
- Public Version Status
- Update
- Public Device Record Key
- f73939a0-1b9e-4084-920d-f4040529dc68
Device Description
Single Use Surgical Scissors FS-200
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTS | Endoscopic grasping/cutting instrument, non-powered, exempt | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46420 | Flexible endoscopic scissors, single-use | A flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14953170401074 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 04953170401077 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]